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Glass Ionomer Cement Sealant in the Prevention of Post-eruptive Fractures in Molars Affected by MIH

NCT03870958 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2020-09-16

No results posted yet for this study

Summary

This trial will compare the application of Glass Ionomer Cement (GIC) sealant with no-intervention for the most clinically- and cost-effective strategy for managing MIH molars without post-eruptive breakdown, in a school setting, using low-technology and child-friendly dental techniques. Methods/Design: This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (age 6-9), presenting at least one MIH molar (n molars = 195,) will have random allocation to treatment with or without the application of a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium). Baseline measures and outcome data will be assessed through participant report and clinical examination. The primary outcome is the presence of post-eruptive fracture and development of caries lesions. Secondary outcomes are: (1) self-reported dental hypersensitivity; (2) oral health-related-quality of life, reported by children; (3) plaque index, (4) gingival health, (5) caries status (according to ICCMS scores) in primary and permanent teeth; (6) the incremental cost-effectiveness. A trained and calibrated examiner will evaluate the treated teeth every six months post treatment for a period of 36 months. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Logistic Regression and Poisson Regression Analysis will be used to analyze the secondary outcomes (α=5%).

Conditions

  • Molar Incisor Hypomineralization

Interventions

PROCEDURE

GIC sealant (GC Fuji TRIAGE®)

Children allocated to this group will receive the same dietary advices and brushing instructions. Additionally, all MIH molars from will receive a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium).

PROCEDURE

Control

Children allocated to this group will receive the same dietary advices and brushing instructions.

Sponsors & Collaborators

  • University of Guadalajara

    collaborator OTHER

  • University of Dublin, Trinity College

    collaborator OTHER

  • Academic Centre for Dentistry in Amsterdam

    collaborator OTHER

  • Isabel Cristina Olegário da Costa

    lead OTHER

Principal Investigators

  • Daniela Hesse, Professor · Academic Centre for Dentistry in Amsterdam

  • Isaac M Pedroza Uribe, MSc · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2019-12-20
Completion
2021-12-20

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870958 on ClinicalTrials.gov